Home NDC 63187-383 Dexamethasone
Product NDC 63187-383
11-digit product format 631870383
Labeler code 63187
Product ID 63187-383_2c918fc8-1110-4bc5-b0a8-230a2b91e67e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexamethasone
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA087916
Marketing category ANDA
Marketing start 1982-08-26
Substance DEXAMETHASONE
Active strength 2 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog .
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL BP RLD, RS 1982-08-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL BP RLD, RS 1982-08-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL BP RLD, RS 1982-08-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL BP 1982-08-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL BP RLD, RS 1982-08-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL BP RLD, RS 1982-08-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL BP 1982-08-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL BP 1982-08-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL BP 1982-08-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL BP 1982-08-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL BP 1982-08-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL BP 1982-08-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL BP 1982-08-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL AB RLD, RS 1982-08-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL BP RLD, RS 1982-08-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A087916-001 DEXAMETHASONE 2MG TABLET / ORAL BP RLD, RS 1982-08-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Dexamethasone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXAMETHASONE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7S5I7G3JQL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197581 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63187-383-05 Dexamethasone 05 in 1 BOTTLE, PLASTIC TABLET 05 3 63187-383-24 Dexamethasone 24 in 1 BOTTLE, PLASTIC TABLET 24 3 63187-383-30 Dexamethasone 30 in 1 BOTTLE, PLASTIC TABLET 30 3 63187-383-60 Dexamethasone 60 in 1 BOTTLE, PLASTIC TABLET 60 3 63187-383-90 Dexamethasone 90 in 1 BOTTLE, PLASTIC TABLET 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-383 DEXAMETHASONE TABLET [PROFICIENT RX LP] 3 Current NDC, Legacy NDC, 5 package rows 20210115_35307d74-aed8-4c6b-9568-2223a4f350bd.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63187-383-05 63187038305 5 TABLET in 1 BOTTLE, PLASTIC (63187-383-05) 5 tablet 2016-09-01 0000-00-00 No No Current 63187-383-24 63187038324 24 TABLET in 1 BOTTLE, PLASTIC (63187-383-24) 24 tablet 2016-09-01 0000-00-00 No No Current 63187-383-30 63187038330 30 TABLET in 1 BOTTLE, PLASTIC (63187-383-30) 30 tablet 2016-09-01 0000-00-00 No No Current 63187-383-60 63187038360 60 TABLET in 1 BOTTLE, PLASTIC (63187-383-60) 60 tablet 2016-09-01 0000-00-00 No No Current 63187-383-90 63187038390 90 TABLET in 1 BOTTLE, PLASTIC (63187-383-90) 90 tablet 2016-09-01 0000-00-00 No No Current